ClinicalTrials.gg
RecruitingNCT07777549Updated Nov 4, 2026

A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)

A Phase 2 interventional study of TRTL-913 and Placebo in Tinnitus, sponsored by Tortugas Neuroscience, Inc.. Recruiting at 10 sites in 2 countries. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Tortugas Neuroscience, Inc. · Phase 2, Interventional, and Treatment

Updated Nov 4, 2026Now RecruitingFirst site in Australia+4 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study will consist of two parts. Double blind Part A will assess the safety, tolerability, and pharmacokinetics of 7 days of dosing in healthy adults, while open label Part B will evaluate the safety, tolerability, and efficacy of a 2-week treatment course in adults with tinnitus.

02

Conditions studied

  • Tinnitus

Browse trials for

Keywords

  • TRTL-913
  • Tinnitus
03

In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 368 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

Tortugas Neuroscience, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Part A Inclusion Criteria:

  1. Healthy male or female adults aged 18 to 64 years (or 65 to 80 years for an elderly cohort, if enrolled), as determined by the investigator.
  2. Able and willing to provide written and comply with all study procedures.
  3. (BMI) 18.0 to 35.0 kilograms per square meter (kg/m\^2) and body weight greater than (>) 50 kilogram (kg).
  4. Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead , as determined by the investigator.
  5. corrected using the Fridericia method (QTcF) of less than or equal to (≤) 450 millisecond (msec) for males or ≤470 msec for females.
  6. Nonsmokers or light smokers (\<10 cigarettes/week or equivalent vaping) for at least 3 months before dosing and willing to abstain during confinement.
  7. Women of must have a negative pregnancy test and agree to use highly effective throughout the required study period.
  8. Male participants must agree to use appropriate contraception and refrain from sperm donation for the required study period.

Part B Inclusion Criteria:

  1. Male or female adults aged 18 to 64 years.
  2. Able and willing to provide written informed consent and comply with study procedures.
  3. Diagnosis of subjective, stable, chronic, non-pulsatile tinnitus.
  4. Generally healthy aside from tinnitus, with no abnormalities on medical history, physical or neurologic examination, vital signs, laboratory tests, or ECG that would interfere with study participation.
  5. BMI 18.0 to 35.0 kg/m\^2 and body weight >50 kg.
  6. Willing to discontinue prohibited medications and substances before study treatment and throughout study participation.
  7. Women of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception throughout the required study period.
  8. Male participants must agree to use appropriate contraception and refrain from sperm donation for the required study period.

Exclusion criteria

Exclusion Criteria:

Part A Exclusion Criteria:

  1. Any acute or chronic medical condition that, in the investigator's opinion, could affect participant safety or study assessments.
  2. Use of prohibited medications, including moderate or strong cytochrome (CY)P450 inhibitors or inducers, or other prohibited foods or supplements before dosing.
  3. History of seizures, epilepsy, significant head injury associated with loss of consciousness, or other conditions or medications that increase seizure risk.
  4. Clinically significant cardiovascular disease, clinically significant abnormalities, long syndrome, torsade de pointes, or a family history of long QT syndrome or sudden cardiac death.
  5. Active infection or clinically significant recent illness before screening or dosing.
  6. Positive test for (HIV), , or .
  7. Clinically significant hepatic or renal impairment or clinically significant laboratory abnormalities.
  8. History of within the past 10 years (except adequately treated nonmelanoma skin cancer or cervical carcinoma in situ).
  9. Current or recent substance or alcohol use disorder or positive drug or alcohol screening.
  10. Current or history of clinically significant psychiatric illness or suicidal ideation or behavior that would increase study risk.
  11. Pregnant, breastfeeding, or planning pregnancy during the study.

Part B Exclusion Criteria:

  1. Current use of, or plans to initiate, pharmacologic or non-pharmacologic treatment for tinnitus during the study.
  2. Regular night-shift work that could interfere with study assessments.
  3. Use of prohibited medications, including moderate or strong CYP450 inhibitors or inducers, or other prohibited foods or supplements before dosing.
  4. History of seizures, epilepsy, significant head injury associated with loss of consciousness, or other conditions or medications that increase seizure risk.
  5. Clinically significant acute or chronic medical condition that, in the investigator's opinion, could affect participant safety or study assessments.
  6. Positive test for HIV, hepatitis B, or hepatitis C.
  7. History of malignancy within the past 10 years (except adequately treated nonmelanoma skin cancer or cervical carcinoma in situ).
  8. Current or recent substance or alcohol use disorder or positive drug or alcohol screening.
  9. Current or history of clinically significant psychiatric illness or suicidal ideation or behavior that would increase study risk.
  10. Pregnant, breastfeeding, or planning pregnancy during the study.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Part A: Multiple Ascending Doses of TRTL-913

    Participants will receive TRTL-913 immediate-release capsules administered once daily (QD) on Day 1 through Day 7.

    Drug: TRTL-913

  • Placebo comparator
    Part A: Placebo

    Participants will receive TRTL-913 matching placebo administered QD on Day 1 through Day 7.

    Drug: Placebo

  • Experimental
    Part B: TRTL-913

    Participants will self-administer TRTL-913 immediate-release capsules QD on Day 1 through Day 14. Additional doses will be based on the results from Part A.

    Drug: TRTL-913

Interventions

  • DrugTRTL-913

    Participants will receive TRTL-913 capsules QD.

  • DrugPlacebo

    Participants will receive TRTL-913 matching placebo capsules QD.

06

What researchers measure

Primary outcomes

  1. Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to Day 16

  2. Part B: Number of Participants With TEAEs and SAEs

    Time frame: Up to Day 21

  3. Part A: Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and Electrocardiograms (ECGs)

    Time frame: Up to Day 16

  4. Part B: Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and ECGs

    Time frame: Up to Day 21

  5. Part A: Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to Day 16

  6. Part B: Number of Participants With Suicidal Ideation or Behavior as Assessed by the C-SSRS

    Time frame: Up to Day 21

Secondary outcomes

  1. Part A: Plasma Concentrations of TRTL-913

    Time frame: From predose on Day 1 through Day 8

  2. Part A: Maximum Observed Plasma Concentration (Cmax) of TRTL-913

    Time frame: From predose on Day 1 through Day 8

  3. Part A: Time to Maximum Plasma Concentration (Tmax) of TRTL-913

    Time frame: From predose on Day 1 through Day 8

  4. Part A: Area Under the Plasma Concentration-Time Curve (AUC(0-t)) of TRTL-913

    Time frame: From predose on Day 1 through Day 8

  5. Part A: AUC From 0 to 24 Hours (AUC(0-24h)) of TRTL-913

    Time frame: From predose on Day 1 through Day 8

  6. Part A: AUC from time 0 extrapolated to infinity (AUC(0-inf)) of TRTL-913

    Time frame: From predose on Day 1 through Day 8

  7. Part A: Apparent Terminal Elimination Half-Life (t1/2) of TRTL-913

    Time frame: From predose on Day 1 through Day 8

  8. Part A: Apparent Total Plasma Clearance After Oral Administration (CL/F) of TRTL-913

    Time frame: From predose on Day 1 through Day 8

  9. Part A: Apparent Volume of Distribution During Terminal Phase (Vz/F) of TRTL-913

    Time frame: From predose on Day 1 through Day 8

  10. Part A: Accumulation Ratio for AUC (Rac AUC) of TRTL-913

    Time frame: From predose on Day 1 through Day 8

  11. Part A: Accumulation Ratio for Cmax (Rac Cmax) of TRTL-913

    Time frame: From predose on Day 1 through Day 8

  12. Part B: Change From Baseline in Tinnitus Functional Index (TFI) Total and Subscale Scores

    Time frame: From Baseline to Day 21

  13. Part B: Change From Baseline in Tinnitus Handicap Inventory (THI) Score

    Time frame: From Baseline to Day 21

  14. Part B: Change From Baseline in the Visual Analog Scale - Loudness (VAS-L) Score

    Time frame: From Baseline to Day 21

  15. Part B: Change From Baseline in Visual Analog Scale - Annoyance (VAS-A) Score

    Time frame: From Baseline to Day 21

07

Study locations

1 of 10 sites recruiting
  • Clinical Trial Site
    Newcastle, New South Wales, Australia
    Not yet recruiting
  • Clinical Trial Site
    Sydney, New South Wales, Australia
    Not yet recruiting
  • Clinical Trial Site
    Waitara, New South Wales, Australia
    Not yet recruiting
  • Clinical Trial Site
    Southport, Queensland, Australia
    Not yet recruiting
  • Clinical Trial Site
    Torquay, Victoria, Australia
    Not yet recruiting
  • Clinical Trial Site
    Auckland, New Zealand
    Recruiting
  • Clinical Trial Site
    Christchurch, New Zealand
    Not yet recruiting
  • Clinical Trial Site
    Nelson, New Zealand
    Not yet recruiting
  • Clinical Trial Site
    Rotorua, New Zealand
    Not yet recruiting
  • Clinical Trial Site
    Wellington, New Zealand
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Oct 2026 (actual). Primary completion is estimated for Aug 2027, 10 months after the start.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Nov 4, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartActual
Oct 14, 2026was Sep 2026
Primary completionEst.
Aug 2027
CompletionEst.
Aug 2027
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 4, 2026
Sites
9 sites added — first site in Australia. Clinical Trial Site is now Recruiting
Show 9 added (5 Australia, 4 New Zealand)
  • Clinical Trial Site · Newcastle, Australia
  • Clinical Trial Site · Sydney, Australia
  • Clinical Trial Site · Waitara, Australia
  • Clinical Trial Site · Southport, Australia
  • Clinical Trial Site · Torquay, Australia
  • Clinical Trial Site · Christchurch, New Zealand
  • Clinical Trial Site · Nelson, New Zealand
  • Clinical Trial Site · Rotorua, New Zealand
  • Clinical Trial Site · Wellington, New Zealand
Nov 4, 2026
Start date
Sep 2026→Oct 14, 2026 (actual)
Nov 4, 2026
Contact
Study contact now listed: added c•••@tortugasneuro.com · •••6470. See the current contact
Nov 4, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Clinical Trial Site · Auckland, New ZealandContact removed c•••@tortugasneuro.com
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Not yet recruiting→Recruiting
    9 sites added — first site in Australia. Clinical Trial Site is now Recruiting
    Show 9 added (5 Australia, 4 New Zealand)
    • Clinical Trial Site · Newcastle, Australia
    • Clinical Trial Site · Sydney, Australia
    • Clinical Trial Site · Waitara, Australia
    • Clinical Trial Site · Southport, Australia
    • Clinical Trial Site · Torquay, Australia
    • Clinical Trial Site · Christchurch, New Zealand
    • Clinical Trial Site · Nelson, New Zealand
    • Clinical Trial Site · Rotorua, New Zealand
    • Clinical Trial Site · Wellington, New Zealand
    Start date Sep 2026→Oct 14, 2026 (now actual)
    Contact Study contact now listed: added c•••@tortugasneuro.com · •••6470. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Clinical Trial Site · Auckland, New ZealandContact removed c•••@tortugasneuro.com
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07777549
Lead sponsor
Tortugas Neuroscience, Inc.
Responsible party
Sponsor
First posted
Aug 20, 2026
Start date
Oct 14, 2026
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Tortugas Neuroscience Clinical Trials Coordinator
Contact
clinicaltrials@tortugasneuro.com
508-834-6470

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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